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6.1 risk and opportunities managed strategically and operational?

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Qualmx, Jan 19, 2019.

  1. Qualmx

    Qualmx Well-Known Member

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    Hi everyone
    I have implemented 9001 2015, but have some doubts in the approach, particularly in 6.1, please help.
    I have seen somewhere that 6.1 should be considered in a strategic and operational criteria. Regarding to opportunities, (is improvement)
    Is it worth it to manage separated improvement found in strategic analysis (swot) and improvements from 10.3?
    Will they need other kind of control?
    If so, why?
    I have a list in a spreadsheet where I do the follow-up of improvement project of 10.3 and I wonder if I could add an improvement project (opportunity) which was detected in the SWOT.
    The same question is for risk
    Thanks
     
  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Good day Qualmx,

    I have seen many clients use SWOT to very good effect for planning risk. The SWOT also is useful for Context... it can also be an ideal tool for coordinating information in Management Review, if managers are comfortable with it. Modified SWOTs can include internal and external issues, for managers' monitoring which issues have changed, why, and what actions to take, if any.

    Them term "considered" is one that does not require documented information. That being the case, the organization is tasked with "demonstrating" consideration of risk in operational criteria. Since that can be demonstrated (described, shown) in any number of ways, I try to discourage the concept that a given tool (such as a spreadsheet) must be used to demonstrate that risk has been considered in operational criteria, as well as the consideration and handling of opportunities and improvements.

    The basic difference between 6.1 and 10.3 is:
    • 6.1 is taken to directly address a recognized risk
    • 10.3 is an improvement upon what was already done
    Neither requires documented information, but Management Review inputs are required to include the effectiveness of actions taken to reduce risk. How you choose to demonstrate that is up to you.
     
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  3. Qualmx

    Qualmx Well-Known Member

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    Thanks jenny
    Don't you think is worth it,that opportunities be treated with more importance because is strategic, is guiding the business, with more vision, while operational is in the operation level?
     
  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I think the term "more importance because is strategic" may be problematic because process level operational controls could be contributing an overwhelming opportunity through process improvements. It may be problematic to presume the process level opportunities bring less value. Let us please be sensitive to opportunities at all levels, so as to avoid neglecting the value of any of them.
     
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  5. Ali.M

    Ali.M Member

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    I think that a risk analysis against the company objectives with a scoring system is also a valuable tool to document and manage risk. As well as identifying risks, it is also important to identify action being taken against the risks.
     
  6. tony s

    tony s Well-Known Member

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    I believe this is a sequel of this thread.